106384 Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Proposed Rules 

1117–0012, 1117–0014, 1117–0021, 

1117–0023, 1117–0029, and 1117–0056. 

An agency may not conduct or sponsor, 

and a person is not required to respond 

to, a collection of information unless it 

displays a currently valid OMB control 

number. 

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on December 13, 2024, by Administrator 

Anne Milgram. That document with the 

original signature and date is 

maintained by DEA. For administrative 

purposes only, and in compliance with 

requirements of the Office of the Federal 

Register, the undersigned DEA Federal 

Register Liaison Officer has been 

authorized to sign and submit the 

document in electronic format for 

publication, as an official document of 

DEA. This administrative process in no 

way alters the legal effect of this 

document upon publication in the 

Federal Register. 

Heather Achbach, 

Federal Register Liaison Officer, Drug 

Enforcement Administration. 

List of Subjects in 21 CFR Part 1308 

Administrative practice and 

procedure, Drug traffic control, 

Reporting and recordkeeping 

requirements. 

For the reasons set out above, DEA 

proposes to amend 21 CFR part 1308 as 

follows: 

PART 1308—SCHEDULES OF 

CONTROLLED SUBSTANCES 

■ 1. The authority citation for 21 CFR 

part 1308 continues to read as follows: 

Authority: 21 U.S.C. 811, 812, 871(b), 

956(b), unless otherwise noted. 

■ 2. In § 1308.11, add paragraph (d)(105) 

to read as follows: 

§ 1308.11 Schedule I. 

* * * * * 

(d) * * * 

* * * * * 

(105) 4-Chloromethcathinone 

(4–CMC, 1-(4-chlorophenyl)- 

2-(methylamino)propan-1- 

one) ....................................... 1239 

* * * * * 

* * * * * 

[FR Doc. 2024–30359 Filed 12–27–24; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–1457] 

Schedules of Controlled Substances: 

Placement of Seven Specific FentanylRelated Substances in Schedule I 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Drug Enforcement 

Administration proposes placing seven 

fentanyl-related substances, as 

identified in this proposed rule, in 

schedule I of the Controlled Substances 

Act. These seven substances fall within 

the definition of fentanyl-related 

substances set forth in the February 6, 

2018 temporary scheduling order. 

Through the Temporary Reauthorization 

and Study of Emergency Scheduling of 

Fentanyl Analogues Act, which became 

law on February 6, 2020, Congress 

extended the temporary control of 

fentanyl-related substances until May 6, 

2021. This temporary order was 

subsequently extended multiple times, 

most recently on December 29, 2022, 

through the Consolidated 

Appropriations Act, 2023, which 

extended the order until December 31, 

2024. If finalized, this action would 

make permanent the existing regulatory 

controls and administrative, civil, and 

criminal sanctions applicable to 

schedule I controlled substances on 

persons who handle (manufacture, 

distribute, import, export, engage in 

research, conduct instructional 

activities or chemical analysis, or 

possess), or propose to handle these 

seven specific controlled substances. 

DATES: Comments must be submitted 

electronically or postmarked on or 

before January 29, 2025. 

Interested persons may file a request 

for a hearing or waiver of hearing 

pursuant to 21 CFR 1308.44 and in 

accordance with 21 CFR 1316.47 and/or 

1316.49, as applicable. Requests for a 

hearing, and waivers of an opportunity 

for a hearing or to participate in a 

hearing, must be received on or before 

January 29, 2025. 

ADDRESSES: Interested persons may file 

written comments on this proposal in 

accordance with 21 CFR 1308.43(g). To 

ensure proper handling of comments, 

please reference ‘‘Docket No. DEA– 

1457’’ on all electronic and written 

correspondence, including any 

attachments. 

• Electronic comments: The Drug 

Enforcement Administration (DEA) 

encourages commenters to submit all 

comments electronically through the 

Federal eRulemaking Portal which 

provides the ability to type short 

comments directly into the comment 

field on the web page or to attach a file 

for lengthier comments. Please go to 

https://www.regulations.gov and follow 

the online instructions at that site for 

submitting comments. Upon completion 

of your submission, you will receive a 

Comment Tracking Number for your 

comment. Submitted comments are not 

instantaneously available for public 

view on Regulations.gov. If you have 

received a Comment Tracking Number, 

your comment has been successfully 

submitted and there is no need to 

resubmit the same comment. 

Commenters should be aware that the 

electronic Federal Docket Management 

System will not accept comments after 

11:59 p.m. Eastern Time on the last day 

of the comment period. 

• Paper comments: Paper comments 

that duplicate electronic submissions 

are not necessary. Should you wish to 

mail a paper comment in lieu of an 

electronic comment, it should be sent 

via regular or express mail to: Drug 

Enforcement Administration, Attn: DEA 

Federal Register Representative/DPW, 

8701 Morrissette Drive, Springfield, 

Virginia 22152. 

• Hearing requests: All requests for a 

hearing and waivers of participation, 

together with a written statement of 

position on the matters of fact and law 

asserted in the hearing, must be filed 

with the DEA Administrator, who will 

make the determination of whether a 

hearing will be needed to address such 

matters of fact and law in the 

rulemaking. Such requests must be sent 

to: Drug Enforcement Administration, 

Attn: Administrator, 8701 Morrissette 

Drive, Springfield, Virginia 22152. For 

informational purposes, a courtesy copy 

of requests for hearing and waivers of 

participation should also be sent to: (1) 

Drug Enforcement Administration, Attn: 

Hearing Clerk/OALJ, 8701 Morrissette 

Drive, Springfield, Virginia 22152; and 

(2) Drug Enforcement Administration, 

Attn: DEA Federal Register 

Representative/DPW, 8701 Morrissette 

Drive, Springfield, Virginia 22152. 

• Paperwork Reduction Act 

Comments: All comments concerning 

collections of information under the 

Paperwork Reduction Act must be 

submitted to the Office of Information 

and Regulatory Affairs, OMB, Attention: 

Desk Officer for DOJ, Washington, DC 

20503. Please state that your comment 

refers to Docket No. DEA–1457. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Terrence L. Boos, Drug and Chemical 


ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Proposed Rules 106385 

1 21 CFR 1308.41 through 1308.45; 21 CFR part 

1316, subpart D. 

2 21 CFR 1316.49. 

3 21 CFR 1308.44(b), 1316.53. 

4 21 U.S.C. 811(a). 

5Schedules of Controlled Substances: Temporary 

Placement of Fentanyl-Related Substances in 

Schedule I, 83 FR 5188 (Feb. 6, 2018). 

Evaluation Section, Diversion Control 

Division, Drug Enforcement 

Administration; Telephone: (571) 362– 

3249. 

SUPPLEMENTARY INFORMATION: In this 

proposed rule, the Drug Enforcement 

Administration (DEA) proposes to 

permanently schedule the following 

seven controlled substances in schedule 

I of the Controlled Substances Act 

(CSA), including their isomers, esters, 

ethers, salts, and salts of isomers, esters, 

and ethers whenever the existence of 

such isomers, esters, ethers, and salts is 

possible within the specific chemical 

designation: 

• para-chlorofentanyl (N-(4- 

chlorophenyl)-N-(1-phenethylpiperidin4-yl)propionamide), 

• ortho-chlorofentanyl (N-(2- 

chlorophenyl)-N-(1-phenethylpiperidin4-yl)propionamide), 

• meta-fluorofuranyl fentanyl (N-(3- 

fluorophenyl)-N-(1-phenethylpiperidin4-yl)furan-2-carboxamide), 

• ortho-methylcyclopropyl fentanyl 

(N-(2-methylphenyl)-N-(1- 

phenethylpiperidin-4- 

yl)cyclopropanecarboxamide), 

• beta-methylacetyl fentanyl (Nphenyl-N-(1-(2-phenylpropyl)piperidin4-yl)acetamide), 

• tetrahydrothiofuranyl fentanyl (N- 

(1-phenethylpiperidin-4-yl)-Nphenyltetrahydrothiophene-2- 

carboxamide), 

• para-fluoro valeryl fentanyl (N-(4- 

fluorophenyl)-N-(1-phenethylpiperidin4-yl)pentanamide). 

Posting of Public Comments 

All comments received in response to 

this docket are considered part of the 

public record. DEA will make comments 

available for public inspection online at 

https://www.regulations.gov, unless 

reasonable cause is given. Such 

information includes personal or 

business identifiers (such as name, 

address, state of federal identifiers, etc.) 

voluntarily submitted by the 

commenter. 

Commenters submitting comments 

which include personal identifying 

information (PII), confidential, or 

proprietary business information that 

the commenter does not want made 

publicly available should submit two 

copies of the comment. One copy must 

be marked ‘‘CONTAINS 

CONFIDENTIAL INFORMATION’’ and 

should clearly identify all PII or 

business information the commenter 

does not want to be made publicly 

available, including any supplemental 

materials. DEA will review this copy, 

including the claimed PII and 

confidential business information, in its 

consideration of comments. The second 

copy should be marked ‘‘TO BE 

PUBLICLY POSTED’’ and must have all 

claimed confidential PII and business 

information already redacted. DEA will 

post only the redacted comment on 

https://www.regulations.gov for public 

inspection. DEA generally will not 

redact additional information contained 

in the comment marked ‘‘TO BE 

PUBLICLY POSTED.’’ The Freedom of 

Information Act applies to all comments 

received. 

For easy reference, an electronic copy 

of this document and supplemental 

information to this proposed scheduling 

action are available at https://

www.regulations.gov. 

Request for Hearing or Appearance; 

Waiver 

Pursuant to 21 U.S.C. 811(a), this 

action is a formal rulemaking ‘‘on the 

record after opportunity for a hearing.’’ 

Such proceedings are conducted 

pursuant to the provisions of the 

Administrative Procedure Act (APA), 5 

U.S.C. 551–559.1 Interested persons, as 

defined in 21 CFR 1300.01(b), may file 

requests for a hearing in conformity 

with the requirements of 21 CFR 

1308.44(a) and 1316.47(a), and such 

requests must: 

(1) state with particularity the interest 

of the person in the proceeding; 

(2) state with particularity the 

objections or issues concerning which 

the person desires to be heard; and 

(3) state briefly the position of the 

person with regard to the objections or 

issues. 

Any interested person may file a 

waiver of an opportunity for a hearing 

or to participate in a hearing in 

conformity with the requirements of 21 

CFR 1308.44(c), together with a written 

statement of position on the matters of 

fact and law involved in any hearing.2

All requests for a hearing and waivers 

of participation, together with a written 

statement of position on the matters of 

fact and law involved in such hearing, 

must be sent to DEA using the address 

information provided above. The 

decision whether a hearing will be 

needed to address such matters of fact 

and law in the rulemaking will be made 

by the Administrator. If a hearing is 

needed, DEA will publish a notification 

of hearing on the proposed rulemaking 

in the Federal Register.3 Further, once 

the Administrator determines a hearing 

is needed to address such matters of fact 

and law in rulemaking, she will then 

designate an Administrative Law Judge 

(ALJ) to preside over the hearing. The 

ALJ’s functions shall only commence 

upon designation, as provided in 21 

CFR 1316.52. 

In accordance with 21 U.S.C. 811 and 

812, the purpose of a hearing would be 

to determine whether parachlorofentanyl, ortho-chlorofentanyl, 

meta-fluorofuranyl fentanyl, orthomethylcyclopropyl fentanyl, betamethylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl meet the 

statutory criteria for placement in 

schedule I, as proposed in this rule. 

Legal Authority 

The CSA provides that proceedings 

for the issuance, amendment, or repeal 

of the scheduling of any drug or other 

substance may be initiated by the 

Attorney General (delegated to the 

Administrator of DEA pursuant to 28 

CFR 0.100) on his own motion, at the 

request of the Secretary of Health and 

Human Services (HHS), or on the 

petition of an interested party.4 This 

proposed action is initiated on the 

Administrator’s own motion and 

supported by, inter alia, a 

recommendation from the Assistant 

Secretary for Health of HHS (Assistant 

Secretary for HHS or Assistant 

Secretary) and an evaluation of all other 

relevant data by DEA. If finalized, this 

action would make permanent the 

existing temporary regulatory controls 

and administrative, civil, and criminal 

sanctions of schedule I controlled 

substances on any person who handles 

or proposes to handle these seven 

substances. 

Background 

On February 6, 2018, pursuant to 21 

U.S.C. 811(h)(1), DEA published an 

order in the Federal Register (83 FR 

5188) temporarily placing fentanylrelated substances, as defined in that 

order, in schedule I of the CSA based 

upon a finding that these substances 

pose an imminent hazard to the public 

safety.5 As discussed below in Factor 3, 

the seven substances named in this 

proposed rule meet the existing 

definition of fentanyl-related substances 

as they are not otherwise controlled in 

any other schedule (i.e., not included 

under another DEA Controlled 

Substance Code Number) and are 

structurally related to fentanyl by one or 

more of the five modifications listed 

under the definition. That temporary 


ddrumheller on DSK120RN23PROD with PROPOSALS1
106386 Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Proposed Rules 

6Schedules of Controlled Substances: Temporary 

Placement of Fentanyl-Related Substances in 

Schedule I; Correction, 85 FR 20155 (Apr. 10, 2020). 7Public Law 116–114, sec. 2, 134 Stat. 103. 

8Public Law 117–328, division O, title VI, sec. 

601. 

9Comprehensive Drug Abuse Prevention and 

Control Act of 1970, H.R. Rep. No. 91–1444, 91st 

Cong., Sess. 1 (1970); reprinted in 1970 

U.S.C.C.A.N. 4566, 4603. 

10The National Forensic Laboratory Information 

System (NFLIS) represents an important resource in 

monitoring illicit drug trafficking, including the 

diversion of legally manufactured pharmaceuticals 

into illegal markets. NFLIS is a comprehensive 

information system that includes data from forensic 

laboratories that handle more than 96% of an 

estimated 1.0 million distinct annual State and 

local drug analysis cases. NFLIS includes drug 

chemistry results from completed analyses only. 

While NFLIS data is not direct evidence of abuse, 

it can lead to an inference that a drug has been 

diverted and abused. See Schedules of Controlled 

Substances: Placement of Carisoprodol Into 

Schedule IV, 76 FR 77330, 77332 (Dec. 12, 2011). 

NFLIS data were queried November 1, 2024. 

order was effective upon the date of 

publication. Pursuant to 21 U.S.C. 

811(h)(2), the temporary control of 

fentanyl-related substances, a class of 

substances as defined in the order, as 

well as the seven specific substances 

already covered by that order, was set to 

expire on February 6, 2020. However, 

on February 6, 2020, as explained in 

DEA’s April 10, 2020 correcting 

amendment),6 Congress extended that 

expiration date until May 6, 2021, by 

enacting the Temporary Reauthorization 

and Study of the Emergency Scheduling 

of Fentanyl Analogues Act.7 This 

temporary order was subsequently 

extended multiple times, most recently 

on December 29, 2022, through the 

Consolidated Appropriations Act, 

2023,8 which extended the order until 

December 31, 2024. Consequently, the 

temporary control of these seven 

substances will remain in effect until 

December 31, 2024, unless it is 

extended. Accordingly, as published 

elsewhere in this issue of the Federal 

Register, the DEA Administrator is 

ordering an extension of this temporary 

order as it relates to these seven 

substances. 

The Administrator, on her own 

motion pursuant to 21 U.S.C. 811(a), is 

initiating proceedings to permanently 

schedule para-chlorofentanyl, orthochlorofentanyl, meta-fluorofuranyl 

fentanyl, ortho-methylcyclopropyl 

fentanyl, beta-methylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl in schedule 

I of the CSA. Pursuant to 21 U.S.C. 

811(b), DEA gathered the necessary data 

and reviewed the available information 

regarding the pharmacology, chemistry, 

trafficking, actual abuse, pattern of 

abuse, and the relative potential for 

abuse for these substances. On April 3, 

2023, in accordance with 21 U.S.C. 

811(b), the Administrator submitted a 

request to the Assistant Secretary to 

provide DEA with a scientific and 

medical evaluation of available 

information and a scheduling 

recommendation for these seven 

substances. 

On October 25, 2024, the Assistant 

Secretary submitted HHS’s scientific 

and medical evaluation and scheduling 

recommendation for parachlorofentanyl, ortho-chlorofentanyl, 

meta-fluorofuranyl fentanyl, orthomethylcyclopropyl fentanyl, betamethylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl and their 

salts to the Administrator. The Secretary 

recommended placing these seven 

fentanyl related substances in schedule 

I of the CSA. In accordance with 21 

U.S.C. 811(c), upon receipt of the 

scientific and medical evaluation and 

scheduling recommendation from HHS, 

DEA reviewed the documents and all 

other relevant data and conducted its 

own eight-factor analysis of the abuse 

potential of these seven substances. 

Proposed Determination To 

Permanently Schedule Seven Specific 

Fentanyl-Related Substances 

As discussed in the background 

section, the Administrator is initiating 

proceedings, pursuant to 21 U.S.C. 

811(a), to permanently add parachlorofentanyl, ortho-chlorofentanyl, 

meta-fluorofuranyl fentanyl, orthomethylcyclopropyl fentanyl, betamethylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl to schedule 

I. DEA reviewed the scientific and 

medical evaluation and scheduling 

recommendation received from HHS, 

and all other relevant data and 

conducted its own eight-factor analysis 

of the abuse potential of these seven 

substances pursuant to 21 U.S.C. 811(c). 

Included below is a brief summary of 

each factor as analyzed by HHS and 

DEA, and as considered by DEA in its 

proposed scheduling action. Readers 

should refer to the full eight-factor 

analyses prepared by HHS and by DEA 

in support of this proposal, which are 

available in their entirety under 

‘‘Supporting Documents’’ of the public 

docket for this proposed rule at https:// 

www.regulations.gov under Docket 

Number ‘‘DEA–1457.’’ 

1. The Drug’s Actual or Relative 

Potential for Abuse 

In addition to considering the 

information HHS provided in its 

scientific and medical evaluation 

document for these seven fentanylrelated substances, DEA also considered 

all other relevant data regarding actual 

or relative potential for abuse of these 

three substances. The term ‘‘abuse’’ is 

not defined in the CSA; however, the 

legislative history of the CSA suggests 

that DEA consider the following criteria 

when determining whether a particular 

drug or substance has a potential for 

abuse: 9

(a) There is evidence that individuals 

are taking the drug or drugs containing 

such a substance in amounts sufficient 

to create a hazard to their health or to 

the safety of other individuals or to the 

community; or 

(b) There is significant diversion of 

the drug or drugs containing such a 

substance from legitimate drug 

channels; or 

(c) Individuals are taking the drug or 

drugs containing such a substance on 

their own initiative rather than on the 

basis of medical advice from a 

practitioner licensed by law to 

administer such drugs in the course of 

his professional practice; or 

(d) The drug or drugs containing such 

a substance are new drugs so related in 

their action to a drug or drugs already 

listed as having a potential for abuse to 

make it likely that the drug will have 

the same potentiality for abuse as such 

drugs, thus making it reasonable to 

assume that there may be significant 

diversions from legitimate channels, 

significant use contrary to or without 

medical advice, or that it has a 

substantial capability of creating 

hazards to the health of the user or to 

the safety of the community. 

Law enforcement seizure data 

indicate that individuals have and are 

using para-chlorofentanyl, orthochlorofentanyl, meta-fluorofuranyl 

fentanyl, beta-methylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl on their 

own initiative rather than on the basis 

of medical advice from a practitioner 

licensed by law to administer such 

drugs in the course of his professional 

practice, especially since there is no 

currently accepted medical use for these 

seven substances. According to the 

National Forensic Laboratory 

Information System (NFLIS-Drug) 10

database, which collects drug 

identification results from drug cases 

submitted to and analyzed by Federal, 

State, and local forensic laboratories, 

there have been 214 reports for parachlorofentanyl, ortho-chlorofentanyl, 

meta-fluorofuranyl fentanyl, betamethylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl between 

2020 and 2024. According to HHS, paraVerDate Sep<11>2014 21:44 Dec 27, 2024 Jkt 265001 PO 00000 Frm 00012 Fmt 4702 Sfmt 4702 E:\FR\FM\30DEP1.SGM 30DEP1

ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Proposed Rules 106387 

11 Drug Enforcement Administration–Veterans 

Affairs (DEA–VA) Interagency Agreement. Binding 

and Functional Activity at Delta, Kappa and Mu 

Opioid Receptors. In Vitro Receptor and 

Transporter Assays for Abuse Liability Testing for 

the DEA by the VA (unpublished data). 

12 in vitro Pharmacology data was collected 

through DEA—Veterans Affairs interagency 

agreement: ‘‘in vitro Receptor and Transporter 

Assays for Abuse Liability Testing for the DEA by 

the VA’’. 

13 Gatch MB. (2024). Test of analgesic effects 

alone and in combination with naltrexone. 

15DDHQ19F00001173, ‘‘Evaluation of Abuse 

Potential of Synthetic Opioids Using in Vivo 

Pharmacological Studies’’ (unpublished data). 

14Solinas M, Panlilio LV, Justinova Z, Yasar S, 

Goldberg SR. (2006). Using drug-discrimination 

techniques to study the abuse-related effects of 

psychoactive drugs in rats. Nat Protoc.1(3):1194– 

206. 15 Drug discrimination is widely used to 

determine whether a new test drug or substance is 

pharmacologically similar to a known drug of 

abuse. 16 DEA–Synthetic Opioids Purchase Agreement 

(2022–2024). Evaluation of synthetic opioid 

substances using analgesia and the drug 

discrimination assay. In Vivo Testing for the DEA 

by Gatch (Univ. of North Texas). 

chlorofentanyl, ortho-chlorofentanyl, 

meta-fluorofuranyl fentanyl, betamethylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl are not 

legally marketed as drugs in the United 

States or anywhere else in the world. 

These substances have no approved 

medical use other than their limited use 

in scientific research. As such, the legal 

sources of the substances are limited to 

legitimate chemical companies 

supplying them for scientific research. 

para-Chlorofentanyl, orthochlorofentanyl, meta-fluorofuranyl 

fentanyl, beta-methylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl are not 

approved for medical use and are not 

formulated or approved for clinical use. 

As such, all use is on an individual’s 

own initiative, rather than on the basis 

of medical advice from a practitioner 

licensed by law to administer drugs. 

Law enforcement seizures and case 

reports demonstrate that individuals are 

taking these seven fentanyl-related 

substances on their own initiative, 

rather than on the basis of medical 

advice from a licensed practitioner. 

Based on available data, parachlorofentanyl, ortho-chlorofentanyl, 

meta-fluorofuranyl fentanyl, orthomethylcyclopropyl fentanyl, betamethylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl, are related 

in their effects to the actions of other 

mu-opioid receptor (MOR) agonists,11

such as fentanyl, that are already listed 

as having potential for abuse. Because 

high doses of MOR agonists can produce 

respiratory depression leading to death, 

these fentanyl-related substances at high 

doses have substantial capability of 

creating hazards to the health of the user 

or to the safety of the community. 

According to HHS, these seven fentanylrelated substances exert their actions at 

least in part through the MOR and thus 

have a high likelihood of having 

substantially similar potential for abuse 

as other schedule I opioids. Both DEA’s 

and HHS’s eight-factor analyses found 

that the abuse potential of these 

substances is similar to other schedule 

I opioids and presents a hazard to the 

health and safety of individuals and the 

community. 

2. Scientific Evidence of the Drug’s 

Pharmacological Effects, if Known 

According to DEA and HHS, the 

pharmacological activity of these 

substances in humans is unknown. Data 

obtained from preclinical studies show 

that these fentanyl-related substances 

(para-chlorofentanyl, orthochlorofentanyl, meta-fluorofuranyl 

fentanyl, ortho-methylcyclopropyl 

fentanyl, beta-methylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl) exhibit a 

pharmacological profile similar to that 

of fentanyl, morphine, and several 

schedule I opioid substances that are 

structurally related to fentanyl. Similar 

to fentanyl and other structurally related 

synthetic opioids, fentanyl-related 

substances namely para-chlorofentanyl, 

ortho-chlorofentanyl, metafluorofuranyl fentanyl, orthomethylcyclopropyl fentanyl, betamethylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl have been 

shown to bind to the mu-opioid 

receptors with varying affinities.12 Also, 

similar to fentanyl and other 

structurally related synthetic opioids, 

these seven fentanyl-related substances 

behave as agonists at the MOR sites in 

in vitro functional studies. 

Studies conducted to examine the 

antinociceptive effect of the seven 

fentanyl-related substances in a warm 

water tail-withdrawal assay and their 

mediation by opioid receptors as 

determined by naltrexone antagonism 

showed these seven fentanyl-related 

substances, similar to fentanyl and 

morphine, produced antinociceptive 

effects as measured by an increase in 

tail withdrawal latency.13 Pre-treatment 

with naltrexone, an opioid receptor 

antagonist, attenuated antinociceptive 

effects of the seven-fentanyl related 

substances. These data demonstrate that 

similar to morphine and fentanyl, parachlorofentanyl, ortho-chlorofentanyl, 

meta-fluorofuranyl fentanyl, orthomethylcyclopropyl fentanyl, betamethylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, parafluoro valeryl fentanyl produced dosedependent antinociception in the warmwater tail-withdrawal assay that can be 

attenuated by naltrexone pre-treatment. 

There is a strong correlation between 

the discriminative stimulus effects of a 

given drug in animals and its subjective 

effects in humans.14 Data from drug 

discrimination studies 15 show that the 

seven-fentanyl related substances fully 

and dose-dependently substitute for the 

discriminative stimulus effects 

produced by morphine in Sprague 

Dawley rats trained to discriminate 3.2 

mg/kg morphine from saline.16 These 

data demonstrate para-chlorofentanyl, 

ortho-chlorofentanyl, metafluorofuranyl fentanyl, orthomethylcyclopropyl fentanyl, betamethylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl, similar to 

morphine (schedule II) and fentanyl 

(schedule II), are mu-opioid receptor 

agonists. 

3. The State of Current Scientific 

Knowledge Regarding the Drug or Other 

Substance 

para-Chlorofentanyl, orthochlorofentanyl, meta-fluorofuranyl 

fentanyl, ortho-methylcyclopropyl 

fentanyl, beta-methylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl are 

synthetic opioids in the 4- 

anilidopiperidine structural class which 

includes fentanyl. As defined in the 

February 6, 2018 temporary scheduling 

order, fentanyl-related substances 

include any substance not otherwise 

controlled in any schedule (i.e., not 

included under any other 

Administration Controlled Substance 

Code Number) that is structurally 

related to fentanyl by one or more of the 

following modifications: 

(A) Replacement of the phenyl 

portion of the phenethyl group by any 

monocycle, whether or not further 

substituted in or on the monocycle; 

(B) substitution in or on the phenethyl 

group with alkyl, alkenyl, alkoxyl, 

hydroxyl, halo, haloalkyl, amino or 

nitro groups; 

(C) substitution in or on the 

piperidine ring with alkyl, alkenyl, 

alkoxyl, ester, ether, hydroxyl, halo, 

haloalkyl, amino or nitro groups; 

(D) replacement of the aniline ring 

with any aromatic monocycle, whether 


ddrumheller on DSK120RN23PROD with PROPOSALS1
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17NFLIS data were queried November 1, 2024. 

NFLIS data reporting is still pending for 2023 and 

2024 due to normal lag time. 

18The National Survey on Drug Use and Health, 

formerly known as the National Household Survey 

on Drug Abuse (NHSDA), is conducted annually by 

the Department of Health and Human Services 

Substance Abuse and Mental Health Services 

Administration (SAMHSA). It is the primary source 

of estimates of the prevalence and incidence of 

nonmedical use of pharmaceutical drugs, illicit 

drugs, alcohol, and tobacco use in the United 

States. The survey is based on a nationally 

representative sample of the civilian, noninstitutionalized population 12 years of age and 

older. The survey excludes homeless people who 

do not use shelters, active military personnel, and 

residents of institutional group quarters such as 

jails and hospitals. The NSDUH provides yearly 

national and state level estimates of drug abuse, and 

includes prevalence estimates by lifetime (i.e., ever 

used), past year and past month abuse or 

dependence. 

19The Substance Abuse and Mental Health 

Services Administration (SAMHSA) is a branch of 

the U.S. Department of Health and Human Services 

(HHS). It is charged with improving the quality and 

availability of prevention, treatment, and 

rehabilitative services in order to reduce illness, 

death disability, and cost to society resulting from 

substance abuse and mental illness. 

or not further substituted in or on the 

aromatic monocycle; and/or 

(E) replacement of the N-propionyl 

group by another acyl group. 

Figure 1: Regions of the Chemical 

Structure of Fentanyl Described in The 

Definition of a Fentanyl-Related 

Substance 

According to the February 6, 2018 

temporary scheduling order, the 

existence of a substance with anyone, or 

any combination, of above-mentioned 

modifications (see figure 1) would meet 

the structural requirements of the 

definition of fentanyl-related 

substances. The present seven 

substances fall within the definition of 

fentanyl-related substances by the 

following modifications: 

1. para-chlorofentanyl: substitution 

on the aniline ring (meets definition for 

modification D); 

2. ortho-chlorofentanyl: substitution 

on the aniline ring (meets definition for 

modification D); 

3. meta-fluorofuranyl fentanyl: 

substitution on the aniline ring and 

replacement of the N-propionyl group 

with another acyl group (meets 

definition for modifications D and E); 

4. ortho-methylcyclopropyl fentanyl: 

substitution on the aniline ring and 

replacement of the N-propionyl group 

with another acyl group (meets 

definition for modifications D and E); 

5. beta-methylacetyl fentanyl: 

substitution on the phenethyl group 

with an alkyl group and replacement of 

the N-propionyl group with another acyl 

group (meets definition for 

modifications B and E); 

6. tetrahydrothiofuranyl fentanyl: 

replacement of the N-propionyl group 

with another acyl group (meets 

definition for modification E); 

7. para-fluoro valeryl fentanyl: 

substitution on the aniline ring and 

replacement of the N-propionyl group 

with another acyl group (meets 

definition for modifications D and E). 

4. Its History and Current Pattern of 

Abuse 

Evidence suggests that the pattern of 

abuse of para-chlorofentanyl, orthochlorofentanyl, meta-fluorofuranyl 

fentanyl, ortho-methylcyclopropyl 

fentanyl, beta-methylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl parallels 

that of prescription opioid analgesics. 

Currently, the United States is in the 

midst of an illicit opioid abuse 

epidemic. There has been a marked 

increase in the encounters of synthetic 

opioids that are structurally related to 

fentanyl that parallels an increase in 

deaths related to synthetic opioids. 

Thus, the recreational abuse of fentanyllike substances continues to be a 

significant concern. These substances 

are distributed to users, often with 

unpredictable outcomes. paraChlorofentanyl, ortho-chlorofentanyl, 

meta-fluorofuranyl fentanyl, betamethylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl have been 

encountered by law enforcement 

officials. 

Law enforcement encountered these 

seven substances in the United States. 

According to the NFLIS 17 database, 214 

reports were registered containing six of 

the substances (para-chlorofentanyl, 

ortho-chlorofentanyl, metafluorofuranyl fentanyl, betamethylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl) from state 

or local forensic laboratories from 2020 

to 2024. ortho-Methylcyclopropyl 

fentanyl was not specifically listed in 

the NFLIS database, although in 2018, 

there were three reports of 

methylcyclopropyl fentanyl. 

5. The Scope, Duration, and 

Significance of Abuse 

The rapid appearance of fentanylrelated substances presents numerous 

challenges for forensic and toxicology 

laboratories. The identification of a new 

substance requires full structural 

elucidation, sometimes requiring 

specialized instrumentation not 

available to all forensic laboratories. 

Laboratories are required to quickly 

adapt testing procedures to identify new 

substances. It remains likely that the 

prevalence of these substances in opioid 

related emergency room admissions and 

deaths is underreported as standard 

immunoassays may not differentiate 

fentanyl from substances structurally 

related to fentanyl. 

The population likely to abuse 

fentanyl-related substances overlaps 

with the population abusing 

prescription opioid analgesics, heroin, 

fentanyl, and other synthetic opioid 

substances. Because abusers of fentanylrelated substances are likely to obtain 

these substances through unregulated 

sources, the identity, purity, and 

quantity are uncertain and inconsistent, 

thus posing significant adverse health 

risks to the end user. The misuse and 

abuse of opioids have been 

demonstrated and are well 

characterized. According to the most 

recent data from the National Survey on 

Drug Use and Health (NSDUH) 18 of the 

Substance Abuse and Mental Health 

Services Administration (SAMHSA),19

in 2023, an estimated 8.9 million people 

aged 12 or older misused opioids in the 

past year, including 8.6 million 

prescription pain reliever misusers and 

660,000 heroin users. In 2023, among 

people aged 12 or older, 828,000 people 

misused fentanyl in the past year. 

NSDUH data show that among people 

aged 12 or older in 2023, 627,000 people 

used illicitly manufactured fentanyl in 

the past year. This population is likely 

to be at risk of abusing fentanyl-related 

substances. Individuals who initiate 

(i.e., use a drug for the first time) use of 

fentanyl-related substances are likely to 

be at risk of developing substance use 

disorder, overdose, and death, similar to 

the risks of other opioid analgesics (e.g., 

fentanyl, morphine, etc.). 

According to HHS, it is highly likely 

that the prevalence of these fentanylrelated substances in emergency room 

admissions and fatalities is under 

reported because standard 

immunoassays may not be sufficient to 

distinguish between fentanyl and 


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Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Proposed Rules 106389 

20Centers for Disease Control and Prevention, 

(2024, April). Understanding the opioid overdose 

epidemic. https://www.cdc.gov/overdoseprevention/about/understanding-the-opioidoverdoseepidemic.html Spencer, M. R., Warner, M., 

Cisewski, J. A., Minin ̃ o, A., Dodds, D., Perera, J., & 

Ahmad, F. B., Estimates of drug overdose deaths 

involving fentanyl, methamphetamine, cocaine, 

heroin, and oxycodone: United States, 2021. Vital 

Statistics Rapid Release (Report No. 27). National 

Center for Health Statistics; Zibbell, J. E., Aldridge, 

A., Grabenauer, M., Heller, D., Duhart Clarke, S., 

Pressley, D., & Smiley-McDonald, H. (2023). 

Associations between opioid overdose deaths and 

drugs confiscated by law enforcement and 

submitted to crime laboratories for analysis, United 

States, 2014–2019: An observational study. The 

Lancet Regional Health—Americas, 25. 

21 DEA–TOX is a DEA-run program whereby 

unused biological samples from victims of drug 

overdoses can be extensively tested for the presence 

of novel psychoactive substances, in addition to 

other drugs of abuse. 

22 Guerrieri D, Kjellqvist F, Kronstrand R, Gre ́en 

H. (2019). Validation and Cross-Reactivity Data for 

Fentanyl Analogs with the Immunalysis Fentanyl 

ELISA. J Anal Toxicol. 43(1):18–24. 

23 Katz R, Kelly W, Hsi A. (1994). Prospectivestudy on the occurrence of withdrawal in critically 

ill children who receive fentanyl by continuousinfusion. Critical Care Medicine 16:763–767. 24See 21 U.S.C. 812(b). 

substances that are structurally related 

to fentanyl. Law enforcement reports 

demonstrate para-chlorofentanyl, orthochlorofentanyl, meta-fluorofuranyl 

fentanyl, ortho-methylcyclopropyl 

fentanyl, beta-methylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl are being 

illicitly distributed and abused. The use 

of these seven fentanyl-related 

substances is likely to increase the 

scope, duration, and significance of 

abuse based on their pharmacological 

similarity to drugs that are abused in the 

current opioid epidemic (e.g., fentanyl). 

6. What, if Any, Risk There Is to the 

Public Health 

The increase in opioid overdose 

deaths in the United States has been 

exacerbated by the availability of potent 

synthetic opioids such as fentanyl and 

numerous other structurally related 

substances in the illicit drug market.20

These substances have a history of being 

trafficked as replacements for other 

opioids, such as heroin and other 

synthetic opioids. Fentanyl is a potent 

synthetic opioid that is primarily 

prescribed for acute and chronic pain 

and is approximately 100 times more 

potent than morphine. As such, fentanyl 

has a high risk of abuse, dependence 

and overdose that can lead to death. 

Because fentanyl-related substances 

have a similar chemical structure to 

fentanyl, these substances are expected 

to have similar biological effects. 

Indeed, these seven fentanyl-related 

substances produced pharmacological 

effects similar to fentanyl. The adverse 

effects of substances structurally related 

to fentanyl on humans are largely 

identical to those of fentanyl and other 

opioid analgesics. These fentanylrelated substances pose the same 

qualitative public health risks as heroin, 

fentanyl, and other opioid analgesic 

substances. The DEA Toxicology 

Testing Program (DEA-Tox) 21 identified 

three drug paraphernalia where parachlorofentanyl was detected. These 

cases occurred between May 2022 and 

June 2024. As the data demonstrate, the 

potential for overdoses exists for these 

substances and these substances pose 

risk to public health. 

According to HHS, the lack of 

hospitalization or fatality for these 

seven fentanyl-related substances is not 

surprising because the enzyme linked 

immunosorbent assay (ELISA) which is 

used to detect fentanyl cross-reacts with 

fentanyl-related substances when 

fentanyl is present above a threshold 

level.22 Thus, fatalities that might be 

associated with the fentanyl-related 

substances may be underreported. As 

with any opioid not approved for 

medical use, the health and safety risks 

for users are high. Public health data 

suggest that para-chlorofentanyl, orthochlorofentanyl, meta-fluorofuranyl 

fentanyl, ortho-methylcyclopropyl 

fentanyl, beta-methylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl may be a 

direct risk to public health. 

7. Its Psychic or Physiological 

Dependence Liability 

According to HHS, the psychic or 

physiologic dependence of these seven 

fentanyl-related substances has not been 

studied in clinical studies and is 

therefore unknown. HHS notes that 

pharmacology data for these substances 

as MOR agonists with known abuse 

potential demonstrates their property of 

producing physical and psychic 

dependence similar to other MOR 

agonists. The discontinuation of the use 

of MOR agonists, such as morphine and 

fentanyl (Schedule II drugs), is 

associated with withdrawal symptoms 

indicative of physical dependence. 

Opioid withdrawal syndrome is 

characterized by central nervous system 

irritability, gastrointestinal dysfunction, 

yawning, diaphoresis, and fever.23

Thus, the pharmacological similarity 

and pattern of abuse of parachlorofentanyl, ortho-chlorofentanyl, 

meta-fluorofuranyl fentanyl, orthomethylcyclopropyl fentanyl, betamethylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl are 

indicative of their potential to possess a 

psychic and physiological dependence 

liability similar to that of other mu 

opioid receptor agonist substances, such 

as heroin and fentanyl. 

8. Whether the Substance is an 

Immediate Precursor of a Substance 

Already Controlled Under the CSA 

para-Chlorofentanyl, orthochlorofentanyl, meta-fluorofuranyl 

fentanyl, ortho-methylcyclopropyl 

fentanyl, beta-methylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl are not 

immediate precursors of any controlled 

substance of the CSA, as defined by 21 

U.S.C. 802(23). 

Conclusion: Based on consideration of 

the scientific and medical evaluation 

and accompanying recommendation of 

HHS, and on DEA’s own eight-factor 

analysis, DEA finds that these facts and 

all relevant data constitute substantial 

evidence of potential for abuse of parachlorofentanyl, ortho-chlorofentanyl, 

meta-fluorofuranyl fentanyl, orthomethylcyclopropyl fentanyl, betamethylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl. As such, 

DEA proposes to permanently schedule 

these seven substances as controlled 

substances under the CSA. 

Proposed Determination of Appropriate 

Schedule 

The CSA establishes five schedules of 

controlled substances known as 

schedules I, II, III, IV, and V. The CSA 

also outlines the findings required to 

place a drug or other substance in any 

particular schedule.24 After 

consideration of the analysis and 

recommendation of the Assistant 

Secretary for HHS and review of all 

other available data, the Administrator 

of DEA, pursuant to 21 U.S.C. 811(a) 

and 812(b)(1), finds that: 

(1) para-Chlorofentanyl, orthochlorofentanyl, meta-fluorofuranyl 

fentanyl, ortho-methylcyclopropyl 

fentanyl, beta-methylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl, similar to 

fentanyl, are mu-opioid receptor 

agonists. The seven fentanyl-related 

substances have analgesic effects, and 

these effects are mediated by m-opioid 

receptor agonism. These substances that 

produce mu-opioid receptor agonist 

effects in the CNS are considered as 

having a high potential for abuse (e.g. 

morphine and fentanyl). Data obtained 

from drug discrimination studies 

indicate that para-chlorofentanyl, orthochlorofentanyl, meta-fluorofuranyl 

fentanyl, ortho-methylcyclopropyl 


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25Pursuant to 21 U.S.C. 812(b)(1)(B), when 

placing a drug or substance in schedule I of the 

CSA, DEA must consider whether the substance has 

a currently accepted medical use in treatment in the 

United States. First, DEA looks to whether the drug 

or substance has FDA approval. When no FDA 

approval exists, DEA has traditionally applied a 

five-part test to a drug or substance to determine 

whether a drug or substance has a currently medical 

use: i. the drug’s chemistry must be known and 

reproducible; ii. there must be adequate safety 

studies; iii. there must be adequate and wellcontrolled studies proving efficacy; iv. the drug 

must be accepted by qualified experts; and v. the 

scientific evidence must be widely available. 

Marijuana Scheduling Petition; Denial of Petition; 

Remand, 57 FR 10499 (Mar. 26, 1992), pet. for rev. 

denied, Alliance for Cannabis Therapeutics v. Drug 

Enforcement Admin., 15 F.3d 1131, 1135 (D.C. Cir. 

1994). DEA applied the traditional five-part test and 

concluded the test was not satisfied. In a recent 

published letter in a different context, HHS applied 

an additional two-part test to determine currently 

accepted medical use for substances that do not 

satisfy the five-part test: (1) whether there exists 

widespread, current experience with medical use of 

the substance by licensed health care providers 

operating in accordance with implemented 

jurisdiction-authorized programs, where medical 

use is recognized by entities that regulate the 

practice of medicine, and, if so, (2) whether there 

exists some credible scientific support for at least 

one of the medical conditions for which part (1) is 

satisfied. On April 11, 2024, the Department of 

Justice’s Office of Legal Counsel (OLC) issued an 

opinion, which, among other things, concluded that 

HHS’s two-part test would be sufficient to establish 

that a drug has a currently accepted medical use. 

Office of Legal Counsel, Memorandum for Merrick 

B. Garland Attorney General Re: Questions Related 

to the Potential Rescheduling of Marijuana at 3 

(April 11, 2024). In its eight-factor assessment, HHS 

determined that these seven fentanyl-related 

substances did not satisfy this two-part test. 

Therefore, since both DEA and HHS have 

determined that these seven fentanyl-related 

substances do not satisfy the five-part test, and HHS 

has determined that these seven fentanyl-related 

substances do not satisfy the additional two-part 

test, DEA concludes that para-chlorofentanyl, 

ortho-chlorofentanyl, meta-fluorofuranyl fentanyl, 

ortho-methylcyclopropyl fentanyl, betamethylacetyl fentanyl, tetrahydrothiofuranyl 

fentanyl, and para-fluoro valeryl fentanyl do not 

have a currently accepted medical use. 

26 21 U.S.C. 812(b)(1). 

fentanyl, beta-methylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl fully 

substituted for the discriminative 

stimulus effects of morphine. Thus, 

these substances have a high potential 

for abuse. 

(2) There is no FDA-approved drug 

application for para-chlorofentanyl, 

ortho-chlorofentanyl, metafluorofuranyl fentanyl, orthomethylcyclopropyl fentanyl, betamethylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl in the 

United States. Further, there are no 

adequate and well-controlled clinical 

studies for any of these substances, and 

there are no well-defined finished 

dosage forms for any of these fentanylrelated substances. There are no known 

therapeutic applications for these seven 

fentanyl-related substances, and thus 

they have no currently accepted medical 

use in the United States.25

(3) There is a lack of accepted safety 

for use of para-chlorofentanyl, orthochlorofentanyl, meta-fluorofuranyl 

fentanyl, ortho-methylcyclopropyl 

fentanyl, beta-methylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl under 

medical supervision. Because these 

seven substances have no FDAapproved medical use and have not 

been investigated as new drugs, their 

safety for use under medical supervision 

has not been determined. Therefore, 

there is a lack of accepted safety for use 

of these seven substances under medical 

supervision. 

Based on these findings, the 

Administrator of DEA concludes that 

para-chlorofentanyl, orthochlorofentanyl, meta-fluorofuranyl 

fentanyl, ortho-methylcyclopropyl 

fentanyl, beta-methylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl, including 

their isomers, esters, ethers, salts, and 

salts of isomers, esters, and ethers 

whenever the existence of such isomers, 

esters, ethers, and salts is possible 

within the specific chemical 

designation, warrant continued control 

in schedule I of the CSA.26

Requirements for Handling paraChlorofentanyl, ortho-Chlorofentanyl, 

meta-Fluorofuranyl fentanyl, orthoMethylcyclopropyl fentanyl, betaMethylacetyl fentanyl, 

Tetrahydrothiofuranyl fentanyl, and 

para-Fluoro valeryl fentanyl 

As discussed above, these seven 

fentanyl-related substances are currently 

subject to a temporary scheduling order, 

which added them to schedule I. If this 

rule is finalized as proposed, parachlorofentanyl, ortho-chlorofentanyl, 

meta-fluorofuranyl fentanyl, orthomethylcyclopropyl fentanyl, betamethylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl would be 

subject, on a permanent basis, to the 

CSA’s schedule I regulatory controls 

and administrative, civil, and criminal 

sanctions applicable to the manufacture, 

distribution, dispensing, importing, 

exporting, research, and conduct of 

instructional activities, including the 

following: 

1. Registration. Any person who 

handles (manufactures, distributes, 

dispenses, imports, exports, engages in 

research, or conducts instructional 

activities or chemical analysis with, or 

possesses) para-chlorofentanyl, orthochlorofentanyl, meta-fluorofuranyl 

fentanyl, ortho-methylcyclopropyl 

fentanyl, beta-methylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl must be 

registered with DEA to conduct such 

activities pursuant to 21 U.S.C. 822, 

823, 957, and 958, and in accordance 

with 21 CFR parts 1301 and 1312. 

2. Security. para-Chlorofentanyl, 

ortho-chlorofentanyl, metafluorofuranyl fentanyl, orthomethylcyclopropyl fentanyl, betamethylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl are subject 

to schedule I security requirements and 

must be handled and stored pursuant to 

21 U.S.C. 821, 823, and in accordance 

with 21 CFR 1301.71 through 1301.76. 

Non-practitioners handling these seven 

substances also must comply with the 

screening requirements of 21 CFR 

1301.90 through 1301.93. 

3. Labeling and Packaging. All labels 

and labeling for commercial containers 

of para-chlorofentanyl, orthochlorofentanyl, meta-fluorofuranyl 

fentanyl, ortho-methylcyclopropyl 

fentanyl, beta-methylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl must 

comply with 21 U.S.C. 825 and 958(e) 

and be in accordance with 21 CFR part 

1302. 

4. Quota. Only registered 

manufacturers are permitted to 

manufacture para-chlorofentanyl, orthochlorofentanyl, meta-fluorofuranyl 

fentanyl, ortho-methylcyclopropyl 

fentanyl, beta-methylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl in 

accordance with a quota assigned 

pursuant to 21 U.S.C. 826 and in 

accordance with 21 CFR part 1303. 

5. Inventory. Any person registered 

with DEA to handle parachlorofentanyl, ortho-chlorofentanyl, 

meta-fluorofuranyl fentanyl, orthomethylcyclopropyl fentanyl, betamethylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl must have 

an initial inventory of all stocks of 

controlled substances (including these 

substances) on hand on the date the 

registrant first engages in the handling 

of controlled substances pursuant to 21 

U.S.C. 827, and in accordance with 21 

CFR 1304.03, 1304.04, and 1304.11. 

After the initial inventory, every DEA 

registrant must take a new inventory of 

all stocks of controlled substances 

(including para-chlorofentanyl, orthochlorofentanyl, meta-fluorofuranyl 

fentanyl, ortho-methylcyclopropyl 

fentanyl, beta-methylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl) on hand 


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27Schedules of Controlled Substances: 

Temporary Placement of Fentanyl-Related 

Substances in Schedule I; Correction, 85 FR 20155 

(Apr. 10, 2020). 

28Public Law 116–114, sec. 2, 134 Stat. 103. 

29Public Law 117–328, division O, title VI, sec. 

601. 

every two years pursuant to 21 U.S.C. 

827 and 958(e) and in accordance with 

21 CFR 1304.03, 1304.04, and 1304.11. 

6. Records and Reports. Every DEA 

registrant must maintain records and 

submit reports with respect to parachlorofentanyl, ortho-chlorofentanyl, 

meta-fluorofuranyl fentanyl, orthomethylcyclopropyl fentanyl, betamethylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl, pursuant to 

21 U.S.C. 827, 832(a), and 958(e), and in 

accordance with 21 CFR 1301.74(b) and 

(c) and 1301.76(b) and parts 1304, 1312, 

and 1317. Manufacturers and 

distributors would be required to submit 

reports regarding para-chlorofentanyl, 

ortho-chlorofentanyl, metafluorofuranyl fentanyl, orthomethylcyclopropyl fentanyl, betamethylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl to the 

Automation of Reports and 

Consolidated Order System pursuant 21 

U.S.C. 827, and in accordance with 21 

CFR parts 1304 and 1312. 

7. Order Forms. Every DEA registrant 

who distributes para-chlorofentanyl, 

ortho-chlorofentanyl, metafluorofuranyl fentanyl, orthomethylcyclopropyl fentanyl, betamethylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl must 

comply with the order form 

requirements, pursuant to 21 U.S.C. 828 

and 21 CFR part 1305. 

8. Importation and Exportation. All 

importation and exportation of parachlorofentanyl, ortho-chlorofentanyl, 

meta-fluorofuranyl fentanyl, orthomethylcyclopropyl fentanyl, betamethylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl must be in 

compliance with 21 U.S.C. 952, 953, 

957, and 958, and in accordance with 21 

CFR part 1312. 

9. Liability. Any activity involving 

para-chlorofentanyl, orthochlorofentanyl, meta-fluorofuranyl 

fentanyl, ortho-methylcyclopropyl 

fentanyl, beta-methylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl not 

authorized by, or in violation of, the 

CSA or its implementing regulations is 

unlawful, and may subject the person to 

administrative, civil, and/or criminal 

sanctions. 

Regulatory Analyses 

Executive Orders 12866, 13563, and 

14094 (Regulatory Review) 

In accordance with 21 U.S.C. 811(a), 

this proposed scheduling action is 

subject to formal rulemaking procedures 

done ‘‘on the record after opportunity 

for a hearing,’’ which are conducted 

pursuant to the provisions of 5 U.S.C. 

556 and 557. The CSA sets forth the 

criteria for scheduling a drug or other 

substance. Such actions are exempt 

from review by the Office of 

Management and Budget (OMB) 

pursuant to section 3(d)(1) of Executive 

Order (E.O.) 12866 and the principles 

reaffirmed in E.O. 13563. E.O. 14094 

modernizes the regulatory review 

process to advance policies that 

promote the public interest and address 

national priorities. 

Executive Order 12988, Civil Justice 

Reform 

This proposed regulation meets the 

applicable standards set forth in 

sections 3(a) and 3(b)(2) of E.O. 12988 

to eliminate drafting errors and 

ambiguity, minimize litigation, provide 

a clear legal standard for affected 

conduct, and promote simplification 

and burden reduction. 

Executive Order 13132, Federalism 

This proposed rulemaking does not 

have federalism implications warranting 

the application of E.O. 13132. The 

proposed rule does not have substantial 

direct effects on the States, on the 

relationship between the National 

Government and the States, or the 

distribution of power and 

responsibilities among the various 

levels of government. 

Executive Order 13175, Consultation 

and Coordination With Indian Tribal 

Governments 

This proposed rule does not have 

tribal implications warranting the 

application of E.O. 13175. It does not 

have substantial direct effects on one or 

more Indian tribes, on the relationship 

between the Federal Government and 

Indian tribes, or on the distribution of 

power and responsibilities between the 

Federal Government and Indian tribes. 

Regulatory Flexibility Act 

The Administrator, in accordance 

with the Regulatory Flexibility Act, 5 

U.S.C. 601–612, has reviewed this rule 

and by approving it, certifies that it will 

not have a significant economic impact 

on a substantial number of small 

entities. On February 6, 2018, DEA 

published an order to temporarily place 

fentanyl-related substances, as defined 

in the order, in schedule I of the CSA 

pursuant to the temporary scheduling 

provisions of 21 U.S.C. 811(h). 

However, as explained in DEA’s April 

10, 2020 correcting amendment,27

Congress extended that expiration date 

until May 6, 2021, by enacting the 

Temporary Reauthorization and Study 

of the Emergency Scheduling of 

Fentanyl Analogues Act.28 This 

temporary order was subsequently 

extended multiple times, most recently 

on December 29, 2022, through the 

Consolidated Appropriations Act, 

2023,29 which extended the order until 

December 31, 2024. DEA estimates that 

all entities handling or planning to 

handle para-chlorofentanyl, orthochlorofentanyl, meta-fluorofuranyl 

fentanyl, ortho-methylcyclopropyl 

fentanyl, beta-methylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl have 

already established and implemented 

systems and processes required to 

handle these substances which meet the 

definition of fentanyl-related 

substances. 

There are currently 170 registrations 

authorized to specifically handle the 

fentanyl-related substances as a class, 

which include one or more of the 

following substances: parachlorofentanyl, ortho-chlorofentanyl, 

meta-fluorofuranyl fentanyl, orthomethylcyclopropyl fentanyl, betamethylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl, as well as 

a number of registered analytical labs 

that are authorized to handle schedule 

I controlled substances generally. Some 

of these entities are likely to be large 

entities. However, since DEA does not 

have information of registrant size, DEA 

conservatively assumes all of 170 

registrants affected by this rule are small 

entities. 

A review of the 170 registrations 

indicates that all entities that currently 

handle para-chlorofentanyl, orthochlorofentanyl, meta-fluorofuranyl 

fentanyl, ortho-methylcyclopropyl 

fentanyl, beta-methylacetyl fentanyl, 

tetrahydrothiofuranyl fentanyl, and 

para-fluoro valeryl fentanyl also handle 

other schedule I controlled substances 

and have established and implemented 

(or maintained) systems and processes 

required to handle these substances. 

Therefore, DEA anticipates that this 

proposed rule will impose minimal or 

no economic impact on any affected 

entities; and thus, will not have a 

significant economic impact on any of 

the 95 affected small entities. Therefore, 


ddrumheller on DSK120RN23PROD with PROPOSALS1
106392 Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Proposed Rules 

30 44 U.S.C. 3501–3521. 

DEA has concluded that this proposed 

rule will not have a significant 

economic impact on a substantial 

number of small entities. 

Unfunded Mandates Reform Act of 1995 

In accordance with the Unfunded 

Mandates Reform Act (UMRA) of 1995, 

2 U.S.C. 1501 et seq., DEA has 

determined and certifies that this action 

would not result in any Federal 

mandate that may result ‘‘in the 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $100,000,000 or more 

(adjusted annually for inflation) in any 

1 year . . . .’’ Therefore, neither a Small 

Government Agency Plan nor any other 

action is required under the UMRA of 

1995. 

Paperwork Reduction Act of 1995 

This proposed rule would not impose 

a new collection or modify an existing 

collection of information under the 

Paperwork Reduction Act of 1995.30

Also, this proposed rule would not 

impose new or modify existing 

recordkeeping or reporting requirements 

on state or local governments, 

individuals, businesses, or 

organizations. However, this proposed 

rule would require compliance with the 

following existing OMB collections: 

1117–0003, 1117–0004, 1117–0006, 

1117–0008, 1117–0009, 1117–0010, 

1117–0012, 1117–0014, 1117–0021, 

1117–0023, 1117–0029, and 1117–0056. 

An agency may not conduct or sponsor, 

and a person is not required to respond 

to, a collection of information unless it 

displays a currently valid OMB control 

number. 

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on December 19, 2024, by Administrator 

Anne Milgram. That document with the 

original signature and date is 

maintained by DEA. For administrative 

purposes only, and in compliance with 

requirements of the Office of the Federal 

Register, the undersigned DEA Federal 

Register Liaison Officer has been 

authorized to sign and submit the 

document in electronic format for 

publication, as an official document of 

DEA. This administrative process in no 

way alters the legal effect of this 

document upon publication in the 

Federal Register. 

Heather Achbach, 

Federal Register Liaison Officer, Drug 

Enforcement Administration. 

List of Subjects in 21 CFR Part 1308 

Administrative practice and 

procedure, Drug traffic control, 

Reporting and recordkeeping 

requirements. 

For the reasons set out above, DEA 

proposes to amend 21 CFR part 1308 as 

follows: 

PART 1308—SCHEDULES OF 

CONTROLLED SUBSTANCES 

■ 1. The authority citation for 21 CFR 

part 1308 continues to read as follows: 

Authority: 21 U.S.C. 811, 812, 871(b), 

956(b), unless otherwise noted. 

■ 2. In § 1308.11: 

■ a. Redesignate paragraphs (b)(104) 

through (109) as paragraphs (b)(111) 

through (116); 

■ b. Redesignate paragraphs (b)(87) 

through (103) as paragraphs (b)(93) 

through (109); 

■ c. Redesignate paragraphs (b)(84) 

through (86) as paragraphs (b)(89) 

through (91); 

■ d. Redesignate paragraphs (b)(82) and 

(83) as paragraphs (b)(86) and (87); 

■ e. Redesignate paragraphs (b)(76) 

through (81) as paragraphs (b)(79) 

through (84); 

■ f. Redesignate paragraphs (b)(59) 

through (75) as paragraphs (b)(61) 

through (77); 

■ g. Redesignate paragraphs (b)(21) 

through (58) as paragraphs (b)(22) 

through (59); and 

■ h. Add new paragraphs (b)(21), (60), 

(78), (85), (88), (92), and (110). 

The additions read as follows: 

§ 1308.11 Schedule I. 

* * * * * 

(b) * * * 

*******

(21) beta-methylacetyl fentanyl (N-phenyl-N-(1-(2-phenylpropyl)piperidin-4-yl)acetamide) ................................................................ 9868 

*******

(60) meta-fluorofuranyl fentanyl (N-(3-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)furan-2-carboxamide) .......................................... 9871 

*******

(78) ortho-chlorofentanyl (N-(2-chlorophenyl)-N-(1-phenethylpiperidin-4-yl)propionamide ................................................................. 9828 

*******

(85) ortho-methylcyclopropyl fentanyl (N-(2-methylphenyl)-N-(1-phenethylpiperidin-4-yl)cyclopropanecarboxamide) ....................... 9849 

*******

(88) para-chlorofentanyl (N-(4-chlorophenyl)-N-(1-phenethylpiperidin-4-yl)propionamide) ................................................................. 9818 

*******

(92) para-fluoro valeryl fentanyl (N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)pentanamide) ....................................................... 9870 

*******

(110) tetrahydrothiofuranyl fentanyl (also known as: tetrahydrothiophene fentanyl) (N-(1-phenethylpiperidin-4-yl)-Nphenyltetrahydrothiophene-2-carboxamide) ..................................................................................................................................... 9869 

*******


ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Proposed Rules 106393 

* * * * * 

[FR Doc. 2024–30798 Filed 12–27–24; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 54 

[REG–124930–21] 

RIN 1545–BQ35 

DEPARTMENT OF LABOR 

Employee Benefits Security 

Administration 

29 CFR Part 2590 

RIN 1210–AC13 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

45 CFR Parts 147 and 156 

[CMS–9903–WN] 

RIN 0938–AU94 

Coverage of Certain Preventive 

Services Under the Affordable Care 

Act 

AGENCY: Internal Revenue Service, 

Department of the Treasury; Employee 

Benefits Security Administration, 

Department of Labor; Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services. 

ACTION: Withdrawal of notice of 

proposed rulemaking. 

SUMMARY: This document withdraws a 

notice of proposed rulemaking that 

appeared in the Federal Register on 

February 2, 2023, regarding coverage of 

certain preventive services under the 

Affordable Care Act. 

DATES: As of December 23, 2024, the 

notice of proposed rulemaking that 

appeared in the Federal Register on 

February 2, 2023, at 88 FR 7236, is 

withdrawn. 

FOR FURTHER INFORMATION CONTACT: Alex 

Krupnick, Internal Revenue Service, 

Department of the Treasury, at (202) 

317–5500; Beth Baum or Matthew 

Meidell, Employee Benefits Security 

Administration, Department of Labor, at 

(202) 693–8335; David Mlawsky, 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, at (410) 786–6851. 

SUPPLEMENTARY INFORMATION: Section 

2713 of the Public Health Service Act 

(PHS Act), as added by the Affordable 

Care Act and incorporated into the 

Employee Retirement Income Security 

Act and the Internal Revenue Code, 

requires non-grandfathered group health 

plans and health insurance issuers 

offering non-grandfathered group or 

individual health insurance coverage to 

provide coverage of certain 

recommended preventive services 

without imposing any cost-sharing 

requirements. These preventive services 

include, with respect to women, under 

comprehensive guidelines supported by 

the Health Resources and Services 

Administration, certain contraceptive 

services. Current regulations include 

exemptions and optional 

accommodations for entities and 

individuals with religious objections or 

non-religious moral objections to 

coverage of contraceptive services. 

On February 2, 2023, the Departments 

of the Treasury, Labor, and Health and 

Human Services (HHS) (collectively, the 

Departments) proposed rules (88 FR 

7236) that sought to resolve longrunning litigation with regard to 

religious objections to providing 

contraceptive coverage, by respecting 

the objecting entities’ religious 

objections while also ensuring that 

women enrolled in plans or coverage 

sponsored, arranged, or offered by 

objecting entities could independently 

obtain contraceptive services at no cost. 

The proposed rules would have 

rescinded the regulation providing for 

an exemption based on non-religious 

moral objections. The proposed rules 

would also have established a new 

individual contraceptive arrangement 

that individuals in plans or coverage 

subject to a religious exemption could 

use to obtain contraceptive services at 

no cost directly from a provider or 

facility that furnishes contraceptive 

services, without any involvement on 

the part of an objecting entity. 

The Departments requested comments 

on all aspects of the proposed rules, as 

well as on a number of specific issues. 

The Departments received 44,825 

comments in response to the proposed 

rules from a range of interested parties, 

including employers, health insurance 

issuers, State Exchanges, State 

regulators, unions, and individuals. The 

Departments received comments on 

specific proposals in the proposed rules, 

as well as general comments on the 

proposals. The Departments also 

received comments that were not related 

to the proposals in the proposed rules. 

The Departments have determined it 

appropriate to withdraw the proposed 

rules at this time to focus their time and 

resources on matters other than 

finalizing these rules. Additionally, in 

light of the volume and breadth of scope 

of the comments received, the 

Departments want to further consider 

the proposals made in the proposed 

rules. Moreover, should the 

Departments decide in the future that it 

is a priority to move forward with a 

rulemaking in this area, the 

Departments want to ensure that they 

will have the benefit of the most up-todate facts and information on these 

important issues as the Departments 

consider how to best implement the 

contraceptive coverage requirements of 

PHS Act section 2713, while respecting 

religious objections to contraception. 

For these independently sufficient 

reasons, the Departments are 

withdrawing the proposed rules, and 

may propose new rules in the future, as 

appropriate to meet these goals. 

This withdrawal does not limit the 

Departments’ ability to make new 

regulatory proposals in the areas 

addressed by the withdrawn proposed 

rules, including new proposals that may 

be substantially identical or similar to 

those described therein. In addition, this 

withdrawal does not affect the 

Departments’ ongoing application of 

existing statutory and regulatory 

requirements or its responsibility to 

faithfully administer the statutory 

requirements the proposed rules would 

have implemented if finalized. 

Douglas W. O’Donnell, 

Deputy Commissioner, Internal Revenue 

Service. 

Lisa M. Gomez, 

Assistant Secretary, Employee Benefits 

Security Administration, Department of 

Labor. 

Xavier Becerra, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2024–31239 Filed 12–23–24; 4:15 pm] 

BILLING CODE 4830–01–P; 4510–29–P; 4120–01–P 

DEPARTMENT OF THE INTERIOR 

National Park Service 

36 CFR Part 7 

[NPS–WHIS–NPS38501; 

PX.P0234207B.00.1–PPPWWHISM0– 

PFE00FEPR.YP0000] 

RIN 1024–AE52 

Whiskeytown Unit, WhiskeytownShasta-Trinity National Recreation 

Area; Bicycling 

AGENCY: National Park Service, Interior. 

ACTION: Proposed rule. 

SUMMARY: The National Park Service 

proposes to amend the special 

regulations for Whiskeytown National 


ddrumheller on DSK120RN23PROD with PROPOSALS1